J&J surgical staplers' recall as severest(Reuters) - The U.S. 单肖有角没有脑猜一肖 Food and Drug Administration warned of risks of serious injury or death from surg
staplers made by Johnson & Johnson’s Ethicon unit, labeling a re
cent recall of the device as its most serious. The recall, initiated early April by Ethicon, covers 92,496 surgical staplers and is now labeled as “Class-1” - the strictest form of recall issued by FDA, where use of faulty
devices may cause serious injur
y or death. J&J’s Ethicon unit confirmed serious injuries to two pa
tients, related to the use of the recalled product, the FDA said. The staplers, regulated as Class I medical devices that do not req
uire a premarket submission to the FDA, are us
ed by surgeons during gastrointestinal procedures. The FDA will hold an advisory committee meeting on May 30 to discuss whether reclassifying the staplers for
internal use as Class II medical de
vices would be appropriate.
The reclassification would subject the staplers t
premarket notification and allow the FDA to establish further regulation on the device.